FDA Posts Draft Guidance on Marketing Exemption for Humanitarian-Use Devices

The Food and Drug Administration is announcing in a Federal Register notice (here) a new draft question and answers document on the Humanitarian Device Exemption (HDE) from normal registration requirements for medical devices (here). Under the exemption, Humanitarian Use Devices (HUD) intended for the treatment or diagnosis of a condition that affects less than 4,000 people in the U.S. per year do not have to meet the effectiveness requirements of normal pre-market approval (PMA) applications. Devices marketed under the Humanitarian Device Exemption cannot in most cases be sold for profit. Comments on the draft guidance are due by June 16.